DEPUY SYNTHES POWER TOOLS SMALL BATTERY DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.010 |
Device Problems
Retraction Problem (1536); Battery Problem (2885); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/09/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported from (b)(6) that during an unspecified surgical procedure, it was observed that the small battery drive had an intermittent function.According to the reporter, the device was running slowly, and so different battery devices were tried with the device and the same results were obtained.It was further reported that the device worked as expected in forward; however, it ran "very slow and weak" in reverse.There was a short delay in surgery; however, the duration time was not specified.A spare device was available to complete the surgery successfully.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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Additional narrative: the actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device ran slow in the reverse and forward positions.It was further determined that the device had low power; the power test could not be started, and was weak.It was determined that the electric motor did not function properly and there was corrosion on the internal components.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component wear from normal use over time.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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